Drug price wars! FDA to be more involved in pricing, according to reports

The Food and Drug Administration (FDA), under new commissioner Scott Gottlieb, will be taking more of an active role in the issues surrounding drug prices, according to recent reports from various US news sources.1–3

Drug prices

After a controversial confirmation as the head of the FDA at the beginning of May where there were reports in the New York Timesof some being unsure on Gottlieb’s abilities to withstand political pressure,4 he has announced plans to speed up generics’ approvals in an effort to increase market competition and lower costs. This will be in line with President Trump’s promise to ease FDA regulations and speed up time to market for drugs, which he stressed when speaking with big pharma company leaders back in January.5

The creation of the ‘drug competition action plan’ will be a shift from the FDA’s longstanding position on drug pricing — previously no attention was made to the cost of the drug simply the safety and efficacy were looked at. Bloomberg reported that in an interview on Monday, Gottlieb specified that the agency will exam ‘how to push forward applications in cases where there are less than three competing generic manufacturers’.2 In this way, cases with few or no competing medicines, which can be indicative with high medication costs, will be highlighted.

Targeting these cases, however, is just one of the ways that have been highlighted in the new agency head’s plans to tackle the issue of drug pricing.

Additionally, the Washington Examiner stated that both Congress and the FDA will be ‘looking at a loophole that major pharmaceutical companies use to stop generic makers from creating a cheaper copy’.1 The loophole is in the form of a safety regulation, which the brand-name companies use as an excuse to not send drug samples to generic manufacturers. Although, generics companies can sue the brand-name companies in these instances, this would involve a lengthy and costly process so legislation to close this loophole has been filed in the House and Senate.

“FDA has an important role to play in preserving the balance between innovation and access and making sure its statutory and regulatory processes are working as intended and not being manipulated in ways that FDA and Congress didn’t intend,” Gottlieb said in an interview with the Morning Consult.3

Further to addressing these issues, the Washington Examinernoted that there could be attention drawn to the reauthorisation of the FDA’s user fee programme, which is due for renewal in July.1 The amendments to this legislation being offered are speeding up approval of generics to compete with older generics and speeding up the approval times for generic drugs.

However, FDA regulatory changes are raising concerns for some Democrats that safety of drugs will take a back seat to speeding up approvals. Speaking to the Washington Examiner Gottlieb responded to these concerns: "What we need to think about is not speeding up the review process or speeding up review times. The question we need to be asking is the overall efficiency of the development process itself."